FDA gives full approval to Ohio sterilization tech with ‘life-saving’ potential
COLUMBUS, Ohio (FOX19) - The FDA gave full approval late Sunday night to technology developed in Ohio that would allow hospitals to sterilize face masks used by frontline healthcare workers fighting COVID-19.
The agency gave only partial approval Friday, prompting Gov. DeWine to speak out against the decision, after which he took the matter to President Trump.
Created by Columbus-based Battelle Memorial Institute, the new tech, placed inside sterilization machines, can sterilize up to 80,000 face masks every day -- masks that are in short supply nationwide.
The CEO of Battelle Memorial Institute, Lewis Von Thaer, says the sterilized masks can be used up to 20 times.
DeWine proposed to the FDA Saturday that the machines be allowed to sterilize at full capacity, but the partial approval only allowed 10,000 masks to be sterilized by each machine per day.
The partial approval also only allowed the machines to be used in Ohio hospitals and in some targeted areas around the country. It prohibited Battelle from sending the machines to other states as well.
DeWine said late Sunday night on Twitter he had a “very productive call” with the FDA on the issue and that he anticipated “a positive announcement soon.”
Shortly afterwards, he released a statement saying the full approval had been received:
“The FDA has authorized Columbus-based Battelle to deploy its groundbreaking technology to sterilize surgical masks without a daily limit, which will allow Battelle to operate at its desired capacity."
DeWine says Battelle will send one machine to New York City and one to Stony Brook, NY, which will provide for the sterilization of up to 160,000 surgical masks for New York’s healthcare workers each day.
“This Ohio-driven solution has the potential to save lives now and in the future across the United States," DeWine said.
Machines will also reportedly be sent to Washington state. As many as 15 additional machines will be sent out in the coming weeks.
“I want to thank President Trump for his leadership and Dr. Hahn of the FDA for approving the use of this life-saving technology that Battelle has developed," DeWine said. "This will not only help Ohio’s healthcare workers on the front lines of the COVID-19 crisis, but Battelle will also be helping health care workers in hot spots throughout the country including New York and Washington state.”
Earlier Sunday, prior to the issue being decided, DeWine had this to say:
“The FDA’s decision to severely limit the use of this life-saving technology is nothing short of reckless. Battelle’s innovative technology has the capability to protect healthcare professionals and first responders in Ohio and across the country, but in this time of crisis, the FDA has decided not to support those who are risking their lives to save others.
"This is a matter of life and death. I am not only disappointed by this development, but I’m also stunned that the FDA would decline to do all it can to protect this country’s frontline workers in this serious time of need.”
During a press conference Sunday evening, President Trump says he spoke to DeWine about the issue.
“We worked on that as soon as I heard from Mike today. I got involved, and the FDA is now involved. We’re trying to get a fast approval for the sterilization of masks,” Trump said. "That would be a tremendous difference. That would be really helpful.”
Ohio Attorney General weighed in Sunday after the president spoke.
“If Battelle’s technology for sterilizing face masks for re-use works safely, limiting it to only 10,000 a day is foolish,” he said on Twitter. “If it doesn’t, allowing it at all is reckless.”
In Ohio there are 29 confirmed deaths, 1,653 confirmed cases, 403 hospitalized and 24,376 people tested, DeWine said.
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